Prescription drug · ANDA
Nystop (Nystatin) NDC 0574-2008
Nystatin 100000 [USP'U]/g · Powder · Topical · Padagis US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0574-2008-02 | 00574200802 | 60 g in 1 BOTTLE, PLASTIC (0574-2008-02)Marketed from Aug 16, 1996 | |
| 0574-2008-15 | 00574200815 | 15 g in 1 BOTTLE, PLASTIC (0574-2008-15)Marketed from Aug 16, 1996 | |
| 0574-2008-30 | 00574200830 | 30 g in 1 BOTTLE, PLASTIC (0574-2008-30)Marketed from Aug 16, 1996 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Nystop
- Generic name (nonproprietary)
- nystatin
- Active ingredients
- Nystatin — 100000 [USP'U]/g
- Dosage form
- Powder
- Route
- Topical
- Labeler
- Padagis US LLCNDC labeler code 0574
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 064118
- Marketing start
- Listing expires
- Other FDA classes
- Polyenes (Chemical structure)
- Identifiers
- Product ID 0574-2008_d0aa24d2-89e9-4067-80f7-97a14ac1c21fSPL ID d0aa24d2-89e9-4067-80f7-97a14ac1c21fSPL set ID e1b4622c-0f9f-4c00-b42c-2aa85a5e3d4fRxCUI 261178, 646456UNII BDF1O1C72E
- Pharmacologic class
- Polyene Antifungal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400574200802followed by a unit qualifier and the quantityPackage 00574-2008-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.
Excerpt only. Read the full label for complete information.
About NDC 0574-2008
- What is NDC 0574-2008?
- 0574-2008 is the product NDC for Nystop (nystatin), Nystatin 100000 [USP'U]/g powder, listed with the FDA by Padagis US LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nystop (Nystatin).
- What is the active ingredient?
- Nystatin.
- Who is the labeler?
- Padagis US LLC, NDC labeler code 0574. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nystop?
- 6 other product NDCs are listed under this name. See all Nystop NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nystop products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nystopnystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Bryant Ranch Prepack | 63629-8696 | 63629-8696-01 |
| Nystopnystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Bryant Ranch Prepack | 63629-8697 | 63629-8697-01 |
| Nystopnystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Bryant Ranch Prepack | 63629-8698 | 63629-8698-01 |
| Nystopnystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Bryant Ranch Prepack | 71335-2845 | 71335-2845-01 |
| Nystopnystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Bryant Ranch Prepack | 71335-2869 | 71335-2869-01 |
| Nystopnystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Bryant Ranch Prepack | 72162-1124 | 72162-1124-0272162-1124-0372162-1124-06 |
Other NDCs under ANDA 064118
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Northstar Rx LLC | 72603-491 |
| Nystopnystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Bryant Ranch Prepack | 63629-8696 |
| Nystopnystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Bryant Ranch Prepack | 63629-8697 |
| Nystopnystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Bryant Ranch Prepack | 63629-8698 |
| Nystopnystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Bryant Ranch Prepack | 71335-2845 |
| Nystopnystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Bryant Ranch Prepack | 71335-2869 |
| Nystopnystatin | Nystatin 100000 [USP'U]/g | PowderTopical | Bryant Ranch Prepack | 72162-1124 |